Description
“ginas” (Global Ingredient Archival System) is the name of the collaborative international effort to realize a global mechanism for substance information exchange. Officially, the software produced by NIH/NCATS is called “GSRS” (Global Substance Registration System). It is most correct to say that “GSRS” is the “software to support the GINAS initiative”. Unofficially, “GINAS” is often used interchangeably with GSRS to refer to the software. A major goal of the GSRS software is to support the ISO 11238 requirements of the IDMP standard.
The main goal of ginas is the production of software, called GSRS, to assist agencies in registering and documenting information about substances found in medicines. The Global Ingredient Archival System provides a common identifier for all of the substances used in medicinal products, utilizing a consistent definition of substances globally, including active substances under clinical investigation, consistent with the ISO 11238 standard.
Globalization presents tremendous challenges and opportunities for national regulatory agencies, the pharmaceutical industry, and global health as a whole. Emerging diseases and the health impacts of catastrophic events respect no national boundaries, nor does the increasing volume of substandard, contaminated, and counterfeit products that overburdens national regulators. Ingredients for pharmaceutical products are typically sourced on a global basis and it is very rare that all ingredients for a single product are produced within one jurisdiction. To regulate the global supply chain efficiently and to better respond to and prepare for catastrophic events it is essential to have a global information system for pharmaceutical ingredients.
ISO 11238 specifically addresses the identification and exchange of regulated information on substances. Working closely with that standard’s authors and regulatory authorities from various countries, NCATS is developing an information system to register and store substance-related information and provide identifiers. This will ensure a robust substance registration system that supports the additional needs of national and regional authorities and is consistent with the ISO 11238 standard. The system will support all substance types described in the 11238 standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.
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API
Update Frequency
Sometimes monthly or every other month. Sometimes longer (quarterly).
Licensing
Please refer to the individual licenses of referenced libraries for further information. The software includes many open source components, with associated open source licenses for their use and distribution, and some commercial components, which are licensed by us for distribution to you as part of this software product. The source code authored by NIH/NCATS are public domain and freely distributable.